Results of Quality Systems

49 results of Quality Systems were found

Process Validation: General Principles and Practices - This guidance outlines the general principles and approaches that FDA considers appropriate elements of process validation for the manufacture of human and animal drug and biological products.

Often considered a necessary evil by the pharmaceutical industry, validation is still understood by many as unrestrained bureaucracy, paperwork, and procedures whose roots and logic are obscure and only serve to slow down progress.

Computer Systems Validation: Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Companies.

A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries elucidates how to train the man power involved in development, manufacturing, auditing, and validation of bio pharmaceuticals on a pilot scale, leading to scale-up production.

Analytical Method Validation and Instrument Performance Verification provides a uniquely practical approach to method validation and instrument performance verification.

This unique cross-disciplinary guide brings sound business practice and engineering innovation together, to help improve testing techniques in new product development.

21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry

Presentation of Cleaning Validation in Pharmaceutical Industry - Arabic.

What the requirements are, which compressed air standards you should be using, how to create a monitoring program, and how HACCP principles apply to your compressed air system.

This video describes various steps in troubleshooting of equipment. It provides information on important concepts such as flags, breakdown and downtime management.
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